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- Ensayo clínico NCT07700264
A Validation Study of the Neuro-cognitive Emotion Monitoring-Intervention (NEMO-I) Application in Adolescents
This study aims to evaluate the validity and effectiveness of NEMO-I (Neuro-cognitive Emotion Monitoring-Intervention), a mobile application designed to help adolescents monitor and manage their cognitive and emotional functioning in everyday settings. NEMO-I delivers evidence-based psychological techniques-such as mindfulness, self-regulation training, and emotion monitoring-in a gamified format consisting of seven brief activities that users can complete at home in about 10 minutes each.
A total of 140 middle and high school students will participate. Participants will complete standardized neuropsychological and psychological assessments before and after the intervention period. During the 21-day intervention period, participants will use the NEMO-I application at home each day at their convenience (a minimum of 10 minutes per day is recommended). By comparing pre- and post-intervention assessment results, this study seeks to determine whether the application produces meaningful benefits for adolescent mental health and to establish its suitability as a digital mental health tool.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Myeongjie Im, MA
- Número de teléfono: +82-10-2588-0859
- Correo electrónico: imj@swu.ac.kr
Ubicaciones de estudio
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Seoul
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Seoul, Seoul, Corea del Sur, 01797
- Seoul Women's University
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Contacto:
- Myeongjie Im, MA
- Número de teléfono: +82-10-2588-0859
- Correo electrónico: imj@swu.ac.kr
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Investigador principal:
- Hyunjoo Song, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Middle or high school students currently enrolled in school
- Using an Android-based smartphone
- Voluntary agreement to participate, with consent from a legal guardian
Exclusion Criteria:
- Borderline intellectual functioning or intellectual disability (IQ below 80)
- Visual or hearing impairment
- Prior diagnosis of intellectual, visual, or hearing impairment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: NEMO-I Intervention Group
Participants in this single-arm study use the NEMO-I mobile application at home for 21 days, at their convenience each day (a minimum of 10 minutes per day is recommended).
Cognitive and emotional outcomes are assessed before and after the intervention period.
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NEMO-I is a mobile application that delivers evidence-based psychological techniques in a gamified format.
It consists of seven brief activities-including facial expression imitation, singing, breathing and stretching with nature sounds, reading tips for everyday concerns, rhythm-based instrument play, room decoration, and mindfulness-each designed to be completed at home in about 10 minutes.
Participants use the application daily during the 21-day intervention period, at their convenience, with a recommended minimum of 10 minutes per day.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in depressive symptoms
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Depressive symptoms are measured using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire.
Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
Change is assessed by comparing pre- and post-intervention scores.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in inhibitory control (Color-Word Stroop Test, CWST)
Periodo de tiempo: Baseline(pre-intervention) and after the 21-day intervention period
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Inhibitory control is assessed using the Color-Word Stroop Test (CWST), which measures the efficiency of the frontal-lobe inhibition process.
Performance is indexed by response time and error rate under the color-word interference condition.
Change is assessed by comparing pre- and post-intervention performance.
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Baseline(pre-intervention) and after the 21-day intervention period
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Change in anxiety symptoms
Periodo de tiempo: Baseline(pre-intervention) and after the 21-day intervention period
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Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire assessing the severity of anxiety-related symptoms.
Higher scores indicate greater anxiety.
Change is assessed by comparing pre- and post-intervention scores.
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Baseline(pre-intervention) and after the 21-day intervention period
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Change in neuro-cognitive and emotional function (NEMO-A)
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Neuro-cognitive and emotional function is assessed using the NEMO-A (Neuro-cognitive Emotion Monitoring-Assessment) application, a tablet-based, game-format assessment consisting of five subtasks.
It measures domains including sustained attention, working memory, emotional sensitivity, emotion processing and recognition, audiovisual emotional integration, cognitive control, and executive function.
Performance is indexed by accuracy and response time, and change is assessed by comparing pre- and post-intervention performance.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in visual attention and processing speed (Children's Color Trails Test, CCTT)
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Visual attention, psychomotor speed, sequential processing, and divided/sustained visual attention are assessed using the Children's Color Trails Test (CCTT).
Performance is indexed by completion time (seconds).
Change is assessed by comparing pre- and post-intervention performance.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in set-shifting ability (Trail Making Test-B, TMT-B)
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Set-shifting ability and cognitive flexibility are assessed using the Trail Making Test-B (TMT-B), which requires alternating between numbers and letters in sequence.
Performance is indexed by completion time (seconds).
Change is assessed by comparing pre- and post-intervention performance.
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Baseline (pre-intervention) and after the 21-day intervention period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in subjective stress
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Subjective stress is measured using a Visual Analog Scale (VAS), on which participants rate their current perceived stress level from 1 (no stress) to 10 (extreme stress).
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in daily stress
Periodo de tiempo: Baseline(pre-intervention) and after the 21-day intervention period
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Daily stress is measured using a 26-item self-report scale assessing stress experienced in everyday domains such as parents, school, academics, peer relationships, appearance, and finances, rated on a 5-point Likert scale.
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Baseline(pre-intervention) and after the 21-day intervention period
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Change in alexithymia
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Difficulty identifying and describing one's own emotions is measured using the Korean version of the 20-item Toronto Alexithymia Scale (TAS-20K), rated on a 5-point Likert scale.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in executive function difficulties (self-report)
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Self-reported executive function difficulties are measured using the Brief Self-Report Questionnaire of Executive Function Difficulty for children and adolescents (40 items), rated on a 3-point Likert scale.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in peer relationship quality
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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The quality of peer relationships is measured using a 13-item self-report scale rated on a 4-point Likert scale, including items reflecting conflict and negative peer interactions.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in problem behaviors (CBCL 6-18, parent report)
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Problem behaviors are assessed using the Child Behavior Checklist for Ages 6-18 (CBCL 6-18), completed by a parent or primary caregiver.
It includes internalizing problems (e.g., anxiety, depression, somatic complaints) and externalizing problems (e.g., rule-breaking, aggressive behavior).
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in ADHD symptoms (ARS, parent report)
Periodo de tiempo: Baseline (pre-intervention) and after the 21-day intervention period
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Attention-deficit/hyperactivity symptoms are assessed using the ADHD Rating Scale (ARS), an 18-item parent-report questionnaire comprising inattention and hyperactivity/impulsivity subscales.
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Baseline (pre-intervention) and after the 21-day intervention period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hyunjoo Song, PhD, Seoul Women's University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SWU-2605-004
- RS-2022-KH126068 (Otro número de subvención/financiamiento: Korea Health Industry Development Institute (KHIDI), Ministry of Health & Welfare, Republic of Korea)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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